BlueCross BlueShield of Tennessee Medical Policy Manual

Mechanized Axial Spinal Distraction Therapy Devices

DESCRIPTION

Mechanized axial spinal distraction therapy, also known as vertebral axial decompression, is a therapy used for lower back pain due to a number of conditions including, but not limited to, herniated discs, degenerative disc disease, sciatica, posterior facet syndrome, lumbosacral strain, radiculopathy, and a condition called internal disc disruption (IDD). The therapy uses a computer-driven table to control the disc decompression.  For the treatment, the individual lies on the table and is subjected to a series of cycles as the table is slowly extended and a distraction force is applied via a pelvic harness. When the desired tension is reached, it is gradually released. This repetitive cycle builds up the individual’s tolerance to stronger distraction forces. Generally, multiple outpatient treatments are administered over a period of time with the intent that the series will result in a considerable reduction in pain.

Several devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. Devices include the VAX-D®, Decompression Reduction Stabilization (DRS®) System, Accu-SPINA® System, DRX-3000®, DRX9000®, SpineMED Decompression Table®, Antalgic-Trak®, Lordex® Traction Unit, and Triton® DTS.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Evidence for the efficacy of vertebral axial decompression using mechanized axial spinal distraction devices on health outcomes is limited. Randomized controlled trials with sham controls and validated outcome measures are required.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Vertebral axial decompression (8.03.09). Retrieved April 10, 2018 from BlueWeb. (6 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. (1997). National Coverage Determination (NCD) for Vertebral Axial Decompression (VAX-D) (160.16). Retrieved May 26, 2015 from http://www.cms.gov.

Choi, J., Hwangbo, G., Park, J., & Lee, S. (2014). The effects of manual therapy using joint mobilization and flexion-distraction techniques on chronic low back pain and disc heights. Journal of Physical Therapy Sciences, 26, 1259-1262. (Level 4 evidence)

U.S. Food and Drug Administration. (2006, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053223. Retrieved July 1, 2016 from http://www.accessdata.fda.gov.

U.S. Food and Drug Administration. (1996, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K951622. Retrieved July 1, 2016 from http://www.accessdata.fda.gov.

U.S. Food and Drug Administration. (2009, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091540. Retrieved July 1, 2016 from http://www.accessdata.fda.gov.

ORIGINAL EFFECTIVE DATE:  2/1/2001

MOST RECENT REVIEW DATE:  5/9/2019

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.